(22 days)
Not Found
No
The summary describes a mechanical device for accessing the portal vein and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used for diagnostic and interventional procedures, which are not explicitly therapeutic in nature. The device description also focuses on its mechanical components for access rather than any therapeutic action.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for transjugular liver access in diagnostic and interventional procedures." The inclusion of "diagnostic" directly indicates a diagnostic purpose.
No
The device description explicitly lists physical components like catheters, puncturing tools, needles, and a bending tool, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "transjugular liver access in diagnostic and interventional procedures." This describes a procedure performed on the patient's body to gain access to an internal anatomical site.
- Device Description: The device components (catheters, puncturing tools, needles, cannula) are all designed for physical insertion and manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a tool for accessing an anatomical site for procedures, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Traveler™ Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
Each Portal Vein Access Set contains a 5F MPA catheter, a puncturing tool that comes in the following variations: 0.038" Stylet with a 5Fr Stylet Catheter (separated with a removable spacer clip) or a 21ga Needle/5Fr Catheter or a 16ga Needle/7Fr Catheter (both are separated with a removable spacer clip) and a bending tool. The 14ga stiffening cannula with cannula sheath and the 16ga needle has a curved end, with a directional handle that indicates the direction of the curve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transjugular liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: In accordance with the Design Failure Modes and Effects Analysis, verification testing was identified to support the substantial equivalence of the modified Traveler Portal Vein Access Set. The tests included: Functional Fit Hemostasis Leak Simulative Use (including component compatibility).
The following testing was leveraged from K201489:
Performance Testing:
Radiopacity
Echogenicity
Corrosion Resistance
Dimensional & Functional Fit
Tensile Strength
Torque Strength Test
Liquid Leakage
Air Leakage
Burst Pressure
Flow Rate
Simulative Use - performance testing including dimensional, surface and compatibility of components
Luer Functional Testing
Shipping Test
Resistance to Fracture Testing
Biocompatibility:
Cytotoxicity (ISO 10993-5)
Sensitization (ISO 10993-10)
Intracutaneous Irritation (ISO 10993-10)
Acute Systemic Toxicity (ISO 10993-11)
Material Mediated Pyrogen (ISO 10993-11)
Hemocompatibility (ISO10993-4)
ASTM Hemolysis – Direct and Indirect Contact
Complement Activation, SC5b-9
In Vivo Thrombogenicity
Platelet and Leucocyte counts
Partial Thromboplastin Time (PTT)
Animal testing was not required for the determination of substantial equivalence.
Clinical testing was not required for the determination of substantial equivalence.
Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 10, 2021
Argon Medical Devices Ana Jimenez-Hughes Senior Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751
Re: K213638
Trade/Device Name: Traveler 0.038" Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: November 17, 2021 Received: November 18, 2021
Dear Ana Jimenez-Hughes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Misti Malone, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213638
Device Name Traveler™ Portal Vein Access Set
Indications for Use (Describe)
The Traveler™ Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date Prepared: November 17, 2021
| Company: | Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens, Texas 75751 USA
Facility Registration number: 1625425 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ana Jimenez-Hughes
Senior Regulatory Affairs Specialist
Phone: 903-676-4276
Fax: 903-677-9396
Email: ana.hughes@argonmedical.com |
| Device Trade
Name: | Traveler™ Portal Vein Access Set |
| Device
Common
Name: | Catheter Introducer |
| Device
Classification: | Introducer, Catheter
Product code, DYB
21 CFR 870.1340
Class II
Review Panel: Cardiovascular Devices |
| Predicate
Device(s): | Primary: K201489 Traveler™ Portal Vein Access Set |
| Description of
the Device: | Each Portal Vein Access Set contains a 5F MPA catheter, a puncturing tool that comes
in the following variations: 0.038" Stylet with a 5Fr Stylet Catheter (separated with a
removable spacer clip) or a 21ga Needle/5Fr Catheter or a 16ga Needle/7Fr Catheter
(both are separated with a removable spacer clip) and a bending tool. The 14ga
stiffening cannula with cannula sheath and the 16ga needle has a curved end, with a
directional handle that indicates the direction of the curve. |
| Indication for
Use: | The Traveler™ Portal Vein Access Set is intended for transjugular liver access in
diagnostic and interventional procedures. |
| Device Modification: | The device modification included in this submission is limited to the removal of the following components from the Traveler™ 0.038" Stylet Portal Vein Access Set, the Traveler™ 21 ga Needle Portal Vein Access Set, and the Traveler™ 16 ga Needle Portal Vein Access Set:
10F Introducer sheath 10F Dilator |
| Substantial Equivalence: | There is no change of intended use or fundamental scientific technology between the proposed modified and predicate device. The proposed modified device has the same indication for use as the predicate, K201489. |
| Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, verification testing was identified to support the substantial equivalence of the modified Traveler Portal Vein Access Set. The tests included: Functional Fit Hemostasis Leak Simulative Use (including component compatibility) The following testing was leveraged from K201489: Performance Testing: Radiopacity Echogenicity Corrosion Resistance Dimensional & Functional Fit Tensile Strength Torque Strength Test Liquid Leakage Air Leakage Burst Pressure Flow Rate Simulative Use - performance testing including dimensional, surface and compatibility of components Luer Functional Testing Shipping Test Resistance to Fracture Testing Biocompatibility Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous Irritation (ISO 10993-10) Acute Systemic Toxicity (ISO 10993-11) | |
4
5
- Material Mediated Pyrogen (ISO 10993-11) O
- o Hemocompatibility (ISO10993-4)
- ASTM Hemolysis – Direct and Indirect Contact
- 트 Complement Activation, SC5b-9
- 트 In Vivo Thrombogenicity
- ' Platelet and Leucocyte counts
- . Partial Thromboplastin Time (PTT)
Animal testing was not required for the determination of substantial equivalence.
Clinical testing was not required for the determination of substantial equivalence.
Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications.
Conclusion: The proposed device modifications to the Traveler™ Portal Vein Access Set do not change its intended use or principles of operation. Based on the Indication for Use, design, and safety and performance testing, the Traveler™ Portal Vein Access Set meets the requirements for its intended use and is substantially equivalent to the predicate device.